Sulfalene (Tablets) Instructions for Use

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

ATC Code

J01ED02 (Sulfalene)

Active Substance

Sulfalene (Rec.INN registered by WHO)

Dosage Form

Sulfalene

Tablets 200 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial sulfonamide drug

Pharmacotherapeutic Group

Antimicrobial agent, sulfonamide

Pharmacological Action

An antibacterial agent with a broad spectrum of action, a sulfonamide derivative. It exerts a very long-lasting bacteriostatic effect.

The mechanism of action is due to competitive antagonism with PABA and competitive inhibition of dihydropteroate synthase, which leads to disruption of dihydrofolic acid synthesis, involved in the synthesis of purines and pyrimidines.

Pharmacokinetics

When taken orally, it is rapidly absorbed; C_max is reached in 4-6 hours. The degree of binding to plasma proteins is low.

After a single parenteral administration of 5-10 ml of a 10% solution, the average therapeutic concentration is maintained for 24 hours.

It penetrates well into body fluids and tissues. It is found in high concentrations in bile. T_1/2 is 65 hours.

It is eliminated slowly (60% of the administered dose is excreted over 9 days), which is due to a high degree of reabsorption from the distal renal tubules after glomerular filtration.

Indications

Infectious diseases caused by microorganisms sensitive to sulfalene, including respiratory tract infections (including bronchitis, pneumonia), biliary tract diseases (cholecystitis, cholangitis), urinary tract infections (pyelitis, cystitis, urethritis), purulent infections of various locations (wound infection, abscesses, mastitis), osteomyelitis, otitis, sinusitis.

ICD codes

Dosage Regimen

Administer orally. Take tablets 30 minutes before a meal.

For daily administration in acute, rapidly progressing infections: on day 1, take a loading dose of 1 g (five 200 mg tablets). On subsequent days, take a maintenance dose of 0.2 g (one 200 mg tablet) once daily.

For intermittent administration in chronic, long-term infections: take a single dose of 2 g (ten 200 mg tablets) once every 7 to 10 days. Continue this regimen for a duration of 1 to 1.5 months.

Do not exceed the recommended doses due to the drug’s slow elimination from the body.

During the entire treatment course, ensure adequate intake of alkaline fluids.

In patients with renal disease (without azotemia), conduct therapy under regular monitoring of blood and urine tests.

Adverse Reactions

Possible headache, dyspepsia (including nausea, vomiting), leukopenia, agranulocytosis, crystalluria, drug fever, allergic reactions.

Contraindications

Hypersensitivity to sulfalene and other sulfonamides; agranulocytosis, hemolytic anemia, drug fever, severe dermatitis, hepatitis, chronic renal failure with azotemia, glucose-6-phosphate dehydrogenase deficiency; pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated for use in hepatitis. Caution should be exercised when using in patients with liver diseases.

Use in Renal Impairment

Contraindicated for use in chronic renal failure with azotemia. Use with caution in patients with kidney diseases (without impaired excretory function); in such cases, treatment should be carried out under the control of blood and urine tests.

Special Precautions

Caution should be exercised when prescribing to patients with hematopoietic system diseases, with decompensated cardiac activity, with liver diseases and impaired renal function. In such cases, treatment is carried out under the control of urine and blood tests.

Considering the slow elimination of sulfalene from the body, the recommended doses should not be exceeded.

During treatment, plenty of alkaline fluids are recommended.

Drug Interactions

With simultaneous use with phenytoin, the risk of toxic reactions increases.

With simultaneous use with methotrexate and other folic acid antagonists, the risk of folic acid deficiency increases.

With simultaneous use, methoxsalen promotes the development of photosensitization.

The effect of sulfalene is enhanced with simultaneous use with diaminopyrimidine derivatives (trimethoprim, tetroxoprim, pyrimethamine).

With simultaneous use of sulfalene with hexamethylenetetramine or with drugs that increase uric acid formation (ammonium chloride), the occurrence of insoluble compounds in the form of calculi in the renal pelvises is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.